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The WallFlex Biliary RX Stent System is in the palliative treatment of biliary strictures produced by malignant neoplasms, and relief of malignant biliary obstructions prior to surgery.

The WallFlex™ Biliary RX Stent System is an implantable biliary self-explaining metal stent that is pre-loaded onto a Delivery System with a working length of 194cm, which allows delivery of the stent into the Biliary system endoscopically. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal and distal ends. WallFlex™ Biliary RX Stent is available uncovered, partially covered, or fully covered with a Permalume™ covering.

The Boston Scientific WallFlex™ Biliary RX Stent System is not an AI/ML device, therefore, the requested information regarding acceptance criteria and performance study details related to AI/ML is not applicable.

The provided FDA 510(k) summary (K223469) describes a medical device, a self-expanding metal stent used for palliative treatment of biliary strictures. The performance data section refers to non-clinical testing performed in accordance with FDA guidance documents for similar devices, specifically addressing:

• Metal Expandable Biliary Stents Premarket Notification (510(k)) Submissions
• Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
• Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

These types of tests typically evaluate mechanical properties, biocompatibility, and magnetic resonance compatibility, rather than AI/ML performance metrics.

Therefore, the requested information categories such as sample size for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not relevant to this device's submission.

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